LifeSignals’ device cover 13 physiological parameters for patient monitoring. Credit: Tada Images / Shutterstock.

California-based medtech company LifeSignals (formerly HMicro) has received 510(k) clearance from the US Food and Drug Administration (FDA) for the UbiqVue 2A multi-parameter system for continuous wireless remote patient monitoring.

Worn on the chest and intended for in or out-of-hospital application, the biosensor continuously collects data on SpO₂ levels – a determinant of what percentage of an individual’s blood is saturated with oxygen – and 12 additional physiological data points, including pulse and respiration rate, photoplethysmography (PPG), and body temperature.

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Data from the biosensor is encrypted and securely transmitted, in near real-time, via a relay app or an access point to a secure cloud-based system, with healthcare professionals able to access UbiqVue data and receive notification alerts through a web portal.

LifeSignals co-founder and CEO Surendar Magar told Medical Device Network that a critical engineering milestone in the device’s development was the integration of SpO₂ monitoring into a chest-based form factor.

Magar said: “Traditional pulse oximetry relies on localised blood flow measurements from areas such as the finger or ear, which are unsuitable for wireless monitoring.”

“The development team overcame these by utilising white light spectral SpO₂ patented technology, licensed from BioIntelliSense, and by carrying out the product-level design and processing technology enhancements in partnership with BioIntellisense.”

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LifeSignals’ chief engineering officer Thomas Varghese added: “From silicon design and wireless coexistence to collecting multiple vital signs from the chest, the UbiqVue System demonstrates the innovation required to meet the growing demands of modern healthcare.”

With FDA approval in hand, Magar said that through global partnerships with OEMs, service providers, IDTFs, and distributors, LifeSignals aims to transform healthcare at scale.

LifeSignalsrecently received a previous FDA approval for the LX1550 multi-parameter remote monitoring platform for measuring five data points, including skin temperature and respiration rate in 2021, before which the agency cleared its LP1100 electrocardiogram (ECG) biosensor and single-use LP1250 ECG and heart rate monitoring biosensor.

In 2020, the company merged its portfolio with the assets of Ireland-based connected health provider Renew Health to form LifeSignals Group.

According to GlobalData’s deals database, LifeSignals completed financing rounds in 2014 and 2016, bringing its total funding to date to around $16m.